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Effect of Exercise and Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause

This study has been completed.
Sponsor:
Collaborators:
University of Erlangen-Nürnberg Medical School
Siemens-Betriebskrankenkasse
Information provided by:
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00663104
First received: April 21, 2008
Last updated: December 2, 2009
Last verified: December 2009
History of Changes
  Purpose

The aim of the study is to compare the effect of a progressive, periodized exercise training designed to impact bone, CHD-risk-factors and menopausal complaints versus the combined effect of exercise and "phytoestrogen" (cimicifuga racemosa; CR). After randomization, 84 females 1-3 year postmenopausal with no medication or illness affecting bone metabolism exercise over 12 months (EG; 42 with, 42 without CR), 42 women serve as wellness-control. Three group training sessions/week will be performed in the EG. Both groups will be individually supplemented with calcium and Vit-D (cholecalciferol).


Condition Intervention Phase
Bone Diseases
Metabolic Syndrome X
Coronary Disease
 Behavioral: exercise
Behavioral: exercise + cimicifuga racemosa
Behavioral: wellness control, placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Exercise and Exercise + Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause

Resource links provided by NLM:

Drug Information available for: Cimicifuga
U.S. FDA Resources

Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Bone Mineral Density [ Time Frame: baseline, 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • body composition [ Time Frame: baseline, 12 month ] [ Designated as safety issue: No ]
  • blood lipids, glucose [ Time Frame: baseline, 12 month ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: baseline, 12 month ] [ Designated as safety issue: No ]
  • 10 year CHD-risk [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]
  • menopausal complaints [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: April 2008
Study Completion Date: November 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
exercise (3 sessions/week)
 Behavioral: exercise
exercise: 3 joint sessions/week for 12 months
Active Comparator: 2
exercise and "phytoestrogen" (cimicifuga racemosa)
 Behavioral: exercise + cimicifuga racemosa
exercise: 3 sessions/week for 12 months,cimicifuga racemosa (40 mg/d)
Placebo Comparator: 3
wellness control, placebo
 Behavioral: wellness control, placebo
2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months, placebo

  Eligibility

Ages Eligible for Study:   45 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1-3 years early postmenopausal
  • Caucasian race

Exclusion Criteria:

  • CHD-diseases
  • thrombosis, embolism
  • fractures at lumbar spine or hip
  • secondary osteoporosis
  • hyperparathyroidism
  • medication, diseases with impact on muscle or bone
  • cancer and hormone derived malign diseases
  • weight reduction of > 5 kg during the last 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663104

Locations
Germany
Institute of Medical Physics
Erlangen, Germany, 91052
Sponsors and Collaborators
University of Erlangen-Nürnberg
University of Erlangen-Nürnberg Medical School
Siemens-Betriebskrankenkasse
Investigators
Principal Investigator: Michael Bebenek, MS University of Erlangen-Nürnberg Medical School
Study Director: Wolfgang Kemmler, PhD University of Erlangen-Nürnberg Medical School
Study Chair: Willi A Kalender, Professor, PhD University of Erlangen-Nürnberg Medical School
  More Information

Publications:

Responsible Party: PD. Dr. Wolfgang Kemmler, Institute of Medical Physics, University of Erlangen-Nurnberg
ClinicalTrials.gov Identifier: NCT00663104     History of Changes
Other Study ID Numbers: OFZ-Trace
Study First Received: April 21, 2008
Last Updated: December 2, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Bavaria: Bavarian Ministry of Science, Research and Art

Keywords provided by University of Erlangen-Nürnberg Medical School:
early menopause
exercise
phytoestrogen
bone
CHD-risk factors

Additional relevant MeSH terms:
Bone Diseases
Coronary Disease
Coronary Artery Disease
Menopause, Premature
Primary Ovarian Insufficiency
Metabolic Syndrome X
Musculoskeletal Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Ovarian Diseases
Adnexal Diseases
 Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013